Actively Recruiting
Study Evaluating FMC-376 in Advanced Solid Tumors with KRAS G12C Mutations Open-Label Phase 1/2 Dose Escalation and Expansion Trial Assessing Safety, Pharmacokinetics, and Clinical Activity
Led by Frontier Medicines Corporation · Updated on 2026-03-18
403
Participants Needed
26
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating FMC-376 in adults with advanced solid tumors that have a specific KRAS G12C mutation. This trial aims to assess the safety, pharmacokinetics, and clinical effects of FMC-376 in patients whose tumors are locally advanced, unresectable, or metastatic. The study is conducted in three parts: Phase 1A (dose escalation), Phase 1B (dose expansion), and Phase 2 (cohort expansion), focusing on multiple dose levels in this patient population. Participants will receive FMC-376 as an oral capsule taken daily. The study explores different dosing schedules across the phases to determine optimal dosing and further evaluate the treatment's effects. The study is open-label, meaning both researchers and participants know which treatment is being administered. During the study, participants will be closely monitored for adverse events and dose limiting toxicities up to 21 days, with safety assessments continuing for approximately 24 months. Researchers will also assess pharmacokinetics and clinical activity of FMC-376. Participants must meet certain health and function criteria before and during the study to ensure safety and reliable results.
CONDITIONS
Official Title
A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
- Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematological, renal, and hepatic function
- Agrees not to participate in another interventional study while receiving study drug
You will not qualify if you...
- Leptomeningeal disease or carcinomatous meningitis
- Clinically significant toxicity resulting from prior cancer therapies
- Known or suspected hypersensitivity to FMC-376 or any components of the study drug
- Condition that would interfere with study drug absorption
- Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data
AI-Screening
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Trial Site Locations
Total: 26 locations
1
University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
2
University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Completed
3
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
4
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, United States, 32746
Completed
5
Northwest Cancer Centers
Dyer, Indiana, United States, 46311
Actively Recruiting
6
The University of Kansas Cancer Center
Fairway, Kansas, United States, 66205
Actively Recruiting
7
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
9
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Community Clinical Trials
Kingwood, Texas, United States, 77339
Completed
12
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
13
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
14
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
15
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
16
Macquarie University
Macquarie Park, New South Wales, Australia, 2109
Actively Recruiting
17
Tasman Health Care
Southport, Queensland, Australia, 4215
Actively Recruiting
18
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia, 5037
Actively Recruiting
19
GenesisCare North Adelaide
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
20
Eastern Health - Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
21
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
22
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 03080
Actively Recruiting
23
Severance Hospital
Seoul, Seodaemun-gu, South Korea, 03722
Actively Recruiting
24
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea, 02841
Actively Recruiting
25
Seoul National University Bundang Hospital
Gyeonggi-do, Seongnam-si, South Korea, 13620
Actively Recruiting
26
The Catholic University of Korea, St. Vincent's Hospital
Gyeonggi-do, Suwon-si, South Korea, 16247
Actively Recruiting
Research Team
M
Medical Lead
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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